The rapid control of severe bleeding at wound sites is of critical importance in wound management, especially for the management of trauma or surgery. During certain types of wound injury in high-stress austere environments, such as a dissected artery on the battlefield, the access hole of shrapnel or a bullet must be closed rapidly to avoid excess blood loss.
The gold standard is the use of sutures, staples, adhesives, cautery or fibrin sealants by surgical personnel to stop the flow of blood and close the wound. Appropriate in a hospital setting, the disadvantage of these closure methods in a field setting, especially for care under fire, is that they take a significant length of time to apply and are required to be performed by an expert.
Several approaches to date have been used to close injured wounds in a field setting. The most common approach is to provide manual pressure over the puncture site to compress the damaged blood vessel until the blood coagulates. This is quite difficult not only because of the high blood flow from an artery, but also because there may be many layers of tissue or fabric that have to be compressed by hand or by strap to staunch blood flow from the site of the injury. Manual pressure is considered passive, because of an inability to initiate or accelerate blood clotting. This inefficiency increases the risk of exsanguination as well as reduces the patient's ability to continue to participate in the action and ambulate to a safer location as it may loosen the clot and increase blood loss.
In another approach to close a vessel puncture site, a tourniquet is attached to the patient's extremity proximal to the injury site. The tourniquet applies pressure and collapses the vessel prior to the injury site, reducing blood loss from the opening. The patient, however, must still remove the tourniquet in a timely manner or risk tissue necrosis that may cause loss of the limb or fatal toxicity. Tourniquets are slow and difficult to maneuver and place around the extremity and require fine motor skills. There are also problems associated with the use of tourniquets due to improper forces exerted by these devices which can cause unwanted blood loss as high pressure arterial blood can move beyond the tourniquet, but lower pressure venous blood is unable to pass, actually causing blood loss.
The use of gauzes, felts, sponges, pads and knitted fabrics as field wound dressing combined with manual pressure or pressure dressings is quite conventional. While utilization of bandage and strap assemblies have been widely accepted for field care, these devices present a number of disadvantages. Strap mechanisms of band assemblies are often relatively structurally complex and are difficult to precisely apply about the chest and junctions (armpit, groin, base of the neck). With this approach, it can take a long time to seal the injured artery or vessel and for the patient to be able to ambulate.
To avoid the foregoing disadvantages of manual pressure approaches, impregnated bandages with clotting agents have been developed to introduce clotting factors percutaneously that speed clotting. One such bandage device, referred to as QuickClot™ and sold by Z-Medica, introduces zeolites to the injured vessel, causing water absorption from the blood to the zeolite to concentrate clotting factors and speed up clot formation. However, the bandage device is still subject to movement during extraction of the wounded patient, which can loosen the clot and cause leakage through the puncture site to increase blood loss. In general, the desirable aspects of hemostats are recognized, but new and improved means of controlling blood loss are in demand.
It would therefore be advantageous to provide a device that would more quickly and effectively close openings (punctures) in the skin to reduce blood loss or for wound closure. The iTClamp™ is such a device, as it would advantageously avoid the aforementioned time of applying manual pressure to the opening, simplify the steps required to close the opening, and more effectively retain the closure device on the wound. In addition, the iTClamp™ device increases the patient's ability to continue to participate in the action and ambulate to a safer location. However, the iTClamp™, as well as other similar clamping devices may be improved by providing mechanical means that allow for better resolution of control in clamping.